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Monoclonal Antibodies
Brentuximab + Lenalidomide for T-Cell Lymphoma
Phase 2
Waitlist Available
Led By John Reneau, MD
Research Sponsored by John Reneau
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 2 lines of skin-directed therapy or one prior line of systemic therapy
AST (SGOT) and ALT (SGPT) =< 5 x ULN in patients with documented hepatic involvement by lymphoma
Must not have
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior study therapy
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Summary
This trial is studying brentuximab vedotin and lenalidomide to see how well they work in treating patients with stage IB-IVB T-cell lymphoma that have come back or do not respond to treatment.
Who is the study for?
This trial is for adults with stage IB-IVB T-cell lymphoma that has returned or isn't responding to treatment. Eligible participants must have tried at least one standard chemotherapy, be in good organ function, and not have certain medical conditions like severe allergies to monoclonal antibodies or active infections. Women of childbearing potential must follow strict pregnancy prevention measures.
What is being tested?
The effectiveness of combining brentuximab vedotin (a monoclonal antibody) with lenalidomide (a chemotherapy drug) is being tested. The goal is to see if this combination works better than previous treatments for patients with relapsed or refractory T-cell lymphoma.
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in organs, blood disorders, fatigue, digestive issues, and increased risk of infection due to the immunosuppressive nature of the drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin lymphoma has returned or didn't respond after initial treatments.
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My liver enzymes are within acceptable limits for someone with lymphoma affecting the liver.
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My skin lymphoma has returned or didn't respond to treatment after 2 skin treatments or 1 body-wide treatment.
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My skin lymphoma has changed into a more aggressive form.
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I have T cell lymphoma, received chemotherapy, and my disease can be measured by scans.
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My T cell lymphoma came back after a stem cell transplant.
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I am able to care for myself and perform daily activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.
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I have a significant history of liver problems, including hepatitis, alcohol abuse, or cirrhosis.
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I haven't had any live-virus vaccines in the last 28 days and don't need any during the study.
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I have severe nerve damage in my hands or feet.
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I am currently on medication to suppress my immune system.
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My lymphoma has not spread to my brain or spinal cord.
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I have never had progressive multifocal leukoencephalopathy.
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I have never had an allogeneic stem cell transplant.
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I have issues that prevent me from properly swallowing pills or absorbing medication.
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My condition worsened within 30 days after my last brentuximab vedotin treatment.
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I have been treated with lenalidomide before.
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My heart condition limits my physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate
Secondary study objectives
Incidence of adverse events according to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Overall survival (OS)
Progression free survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (brentuximab vedotin, lenalidomide)Experimental Treatment3 Interventions
Patients receive brentuximab vedotin IV over 30 minutes on day 1 and lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Brentuximab vedotin
FDA approved
Find a Location
Who is running the clinical trial?
John ReneauLead Sponsor
3 Previous Clinical Trials
67 Total Patients Enrolled
John Reneau, MD5.01 ReviewsPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
2 Previous Clinical Trials
55 Total Patients Enrolled
5Patient Review
Reneau is not only skilled in their field, but they are also compassionate. They make it a priority to listen to your concerns and deliver bad news in the most comforting way possible. I have full confidence in their abilities and would recommend them to anyone.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it was either early stage, treated over 2 years ago, or under surveillance without treatment.I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.I have a significant history of liver problems, including hepatitis, alcohol abuse, or cirrhosis.I can understand and willingly sign a consent form.I have a type of skin lymphoma that is not mycosis fungoides.I have severe nerve damage in my hands or feet.I have active hepatitis B or C, or need to take precautions due to hepatitis B.My skin lymphoma has returned or didn't respond after initial treatments.I am currently on medication to suppress my immune system.My liver enzymes are within acceptable limits for someone with lymphoma affecting the liver.I've been cancer-free for 5 years, except for minor skin cancers or early-stage prostate cancer.My skin lymphoma has returned or didn't respond to treatment after 2 skin treatments or 1 body-wide treatment.I don't have any health issues that could affect my safety or interfere with the study medication.My condition worsened within 30 days after my last brentuximab vedotin treatment.I have been treated with lenalidomide before.My skin lymphoma has changed into a more aggressive form.I have T cell lymphoma, received chemotherapy, and my disease can be measured by scans.My cancer was tested for CD30, but it doesn't need to be positive.I am following strict birth control and pregnancy testing as required.I haven't had any live-virus vaccines in the last 28 days and don't need any during the study.My lymphoma has not spread to my brain or spinal cord.I have not had major surgery in the last 6 weeks.I have never had progressive multifocal leukoencephalopathy.I have never had an allogeneic stem cell transplant.I have issues that prevent me from properly swallowing pills or absorbing medication.My T cell lymphoma came back after a stem cell transplant.I have taken brentuximab vedotin but did not worsen during or right after treatment, and it's been 3 months since my last dose.I stopped all cancer treatments at least 1 week ago, or longer if needed, but may still be on low-dose steroids.My heart condition limits my physical activity.I am able to care for myself and perform daily activities.I may have taken steroids for my condition up to a day before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (brentuximab vedotin, lenalidomide)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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